Details for New Drug Application (NDA): 215972
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NDA 215972 describes RAMELTEON, which is a drug marketed by Actavis Labs Fl Inc, Andas 5 Holding, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Upsher Smith Labs, Xiromed, and Zydus Pharms, and is included in ten NDAs. It is available from twenty-three suppliers. Additional details are available on the RAMELTEON profile page.
The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
The generic ingredient in RAMELTEON is ramelteon. There are three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
Summary for 215972
| Tradename: | RAMELTEON |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | ramelteon |
| Patents: | 0 |
Pharmacology for NDA: 215972
| Mechanism of Action | Melatonin Receptor Agonists |
Suppliers and Packaging for NDA: 215972
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAMELTEON | ramelteon | TABLET;ORAL | 215972 | ANDA | Aurobindo Pharma Limited | 59651-505 | 59651-505-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-505-01) |
| RAMELTEON | ramelteon | TABLET;ORAL | 215972 | ANDA | Aurobindo Pharma Limited | 59651-505 | 59651-505-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-505-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | Jul 10, 2023 | TE: | AB | RLD: | No | ||||
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